MAUDE Adverse Event Report: MEDTRONIC SPINE/MEDTRONIC SOFAMOR DANEK USA, INC. SPINAL FUSION SCREW 8.5 X 60MM; PEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC SCOLIOSIS

Catalog Number 55840008560

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 05/04/2023

Event Type  Injury  

Event Description

Broken iliac screw removed in spinal surgery.

• Brand Name: SPINAL FUSION SCREW 8.5 X 60MM
• Type of Device: PEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC SCOLIOSIS
• Manufacturer (Section D): MEDTRONIC SPINE/MEDTRONIC SOFAMOR DANEK USA, INC.
• MDR Report Key: 16974614
• MDR Text Key: 315787497
• Report Number: MW5117738
• Device Sequence Number: 1
• Product Code: OSH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 55840008560
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 66 KG
• Patient Ethnicity: Hispanic